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About
This is a cohort-based, open-label dose escalation and expansion study in adults with advanced solid tumors or lymphoma, refractory or resistant to standard therapy, or without available standard or curative therapy.
Enrollment
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Adult 18 to 75 years old at screening
Pathologically-confirmed, locally advanced or metastatic unresectable solid tumor of an acceptable histology
Part A (Dose Escalation)
Part B (Dose Expansion)
Protocol-defined measurable disease
Available tumor biopsy representative of current disease
ECOG performance status grade 0-2
Life expectancy of ≥ 3 months
Recovery to ≤ Grade 1 for any non-laboratory toxicity resulting from previous anticancer therapy prior to first dose of ALPN-202 (except alopecia, hearing loss, ≤ Grade 2 neuropathy or endocrinopathy managed with replacement therapy)
Adequate baseline hematologic, renal, and hepatic function
Key Exclusion Criteria:
History of ≥ Grade 3 immune-related adverse event leading to treatment discontinuation
Active or prior pneumonitis or interstitial lung disease
Presence of any active central nervous system metastases
Prior organ allograft or allogeneic hematopoietic stem cell transplantation
Any serious or uncontrolled health condition, which, in the opinion of the Investigator, would place the subject at undue risk from the study, impair the ability of the subject to receive protocol specified therapy, or interfere with the interpretation of study results.
Receipt of any protocol-restricted therapy within the timeframes indicated:
Any active, known, or suspected autoimmune disease
Systemic treatment with corticosteroids (> 10 mg/day prednisone) or other immunosuppressive medication
Any second malignancy active within the previous 3 years
Active infection requiring therapy at the time of the first dose of ALPN-202.
Known seropositivity for or active infection by human immunodeficiency virus, hepatitis B or C.
Known allergies, hypersensitivity, or intolerance to ALPN-202 or excipients in the drug product formulation.
History of Grade 4 infusion-related, anaphylactic or allergic reaction to any previous Fc-based protein therapy.
Primary purpose
Allocation
Interventional model
Masking
62 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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